analyst presentation august 10, 2021 · 2021. 8. 10. · pivotal phase 3 trial –final data...
TRANSCRIPT
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Valneva Reports H1 2021 Financial Results
and Provides Business Update
Analyst Presentation
August 10, 2021
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Disclaimer
This presentation does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, Valneva SE shares to anyperson in the USA or in any jurisdiction to whom or in which such offer or solicitation is unlawful.Valneva is a European company. Information distributed is subject to European disclosure requirements that are different from those of theUnited States. Financial statements and information may be prepared according to accounting standards which may not be comparable tothose used generally by companies in the United States.This presentation includes only summary information provided as of the date of this presentation only and does not purport to becomprehensive. Any information in this presentation is purely indicative and subject to modification at any time without notice. Valneva doesnot warrant the completeness, accuracy or correctness of the information or opinions contained in this presentation. None of Valneva, orany of their affiliates, directors, officers, advisors and employees is under any obligation to update such information or shall bear any liabilityfor any loss arising from any use of this presentation. The information has not been subject to independent verification and is qualified in itsentirety by the business, financial and other information that Valneva is required to publish in accordance with the rules, regulations andpractices applicable in particular to companies listed on the regulated market of Euronext in Paris, including in particular the risk factorsdescribed in Valneva’s most recent universal registration document filed with the French Financial Markets Authority (Autorité des MarchésFinanciers, or AMF) and the Form F-1 filed with the U.S. Securities and Exchange Commission on May 5, 2021, as well as in any otherperiodic report and in any other press release, which are available free of charge on the websites of Valneva (www.valneva.com) and/or theAMF (www.amffrance.org).Certain information and statements included in this presentation are not historical facts but are forward-looking statements, includingstatements with respect to revenue guidance, the progress, timing, completion, and results of research, development and clinical trials forproduct candidates and estimates for future performance. The forward-looking statements (a) are based on current beliefs, expectationsand assumptions, including, without limitation, assumptions regarding present and future business strategies and the environment in whichValneva operates, and involve known and unknown risk, uncertainties and other factors, which may cause actual results, performance orachievements to be materially different from those expressed or implied by these forward-looking statements, (b) speak only as of the datethis presentation is released, and (c) are for illustrative purposes only. Investors are cautioned that forward-looking information andstatements are not guarantees of future performances and are subject to various risks and uncertainties, many of which are difficult topredict and generally beyond the control of Valneva.
Non-IFRS Financial MeasuresManagement uses and presents IFRS results as well as the non-IFRS measure of EBITDA to evaluate and communicate its performance.While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures areuseful as an aid to further understand Valneva's current performance, performance trends, and financial condition.EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measureprovide additional analytical tools. EBITDA is defined as earnings (loss) from continuing operations before interest expense, income taxes,depreciation and amortization.A reconciliation of EBITDA to operating profit (loss), the most directly comparable IFRS measure, is set forth in this presentation.
August 10, 2021Valneva H1 2021 Analyst Presentation 2
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Agenda
August 10, 2021Valneva H1 2021 Analyst Presentation 3
Introduction
Business Update
Financial Report H1 2021
Newsflow
Q&A
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Valneva Reports H1 2021 Financial Results and Provides
Business Update
August 10, 2021Valneva H1 2021 Analyst Presentation 4
Major R&D objectives achieved
Positive topline Phase 3 results for chikungunya vaccine
candidate VLA1553
› World’s first ever Phase 3 trial results for a
chikungunya vaccine
Excellent progress on unique clinical assets
› Lyme – recruitment completed for Phase 2 trial
VLA15-221 including pediatric age group
› COVID-19 – recruitment completed for pivotal
Phase 3 trial VLA2001-301
Strong financial position and platform
$107.6 million raised in US IPO
Cash and cash equivalents of €329.8m at June 30, 2021
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Agenda
August 10, 2021Valneva H1 2021 Analyst Presentation 5
Introduction
Business Update
Financial Report H1 2021
Newsflow
Q&A
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0
10
20
30
40
50
60
70
80
90
100
Seroprotection Rate
Pe
rcen
tage
of
su
bje
cts
with
se
rop
rote
ctive
CH
IKV
ne
utr
aliz
ing a
ntib
od
y tite
r
Seroprotection Rate At Day 29 in Baseline Seronegative Subjects, Per-Protocol Population
Placebo VLA1553 Total VLA1553-Younger Adults VLA1553-Elderly
VLA1553-301: Primary Endpoint Met
August 10, 2021Valneva H1 2021 Analyst Presentation 6
* The lower bound of the 95% Confidence Interval for the Seroprotection Rate needed to exceed 70%
Neutralizing antibody titers determined using a µPRNT50 assay
Protective CHIKV Neutralizing Antibody Titers Reported in 98.5% of
Subjects After a Single Shot
Error Bars
represent 95%CI
FDA non-
acceptance
margin*
N=268 N=209 N=59N=73
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VLA1553-301: High Neutralizing Antibodies
August 10, 2021Valneva H1 2021 Analyst Presentation 7
Chikungunya virus neutralizing antibody titers were determined using a µPRNT50 assay. Values below the quantification limit are set to 10.
Highly Immunogenic Across All Age Groups Including Elderly
1
10
100
1000
10000
Day 29
CH
IKV
ne
utr
aliz
ing
an
tib
od
ytite
r
GMT for ChikV Neutralizing Antibodies in Baseline Seronegative Subjects, Per-Protocol Population
Placebo VLA1553-Total VLA1553-Younger Adults VLA1553-Elderly
Error Bars
represent 95%CI
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VLA1553 - Well Tolerated Across All Age Groups
Safety was evaluated in 3,082 participants who received VLA1553
Independent Data Safety Monitoring Board continuously monitored the study and
identified no safety concerns
Safety profile consistent with Phase 1:
› Majority of solicited adverse events were mild or moderate and resolved within 3
days.
- 1.6% reported severe solicited adverse events, most commonly fever
› Approximately 50% of study participants experienced solicited systemic adverse
events, most commonly1 headache, fatigue and myalgia
› Approximately 15% of participants experienced solicited local adverse events
Equally good safety profile in elderly
Final safety analysis expected within the next six months
August 10, 2021Valneva H1 2021 Analyst Presentation 8
1 Seen in more than 20% of subjects
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VLA1553: Development Outlook
August 10, 2021Valneva H1 2021 Analyst Presentation 9
1 Valneva Announces Positive Phase 3 Pivotal Results for its Single-Shot Chikungunya Vaccine Candidate; 2 Valneva Initiates Phase 3 Clinical Lot Consistency Study for its Single-Shot
Chikungunya Vaccine Candidate. 3 In collaboration with development partner Instituto Butantan, under CEPI funding; 4 Valneva Announces Publication of 2020 Universal Registration
Document and Provides Business Updates 5 https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program.
Pivotal Phase 3 Trial – Final Data Expected Within the Next 6 Months
Most advanced clinical development program in the world
Pivotal Phase 3 safety and immunogenicity trial progressing towards final analysis,
expected within the next six months1
Lot-to-Lot consistency trial fully recruited (VLA1553-302), data expected late 20212
Antibody persistence follow-up trial (VLA1553-303) ongoing – up to 375 volunteers
from VLA1553-301 will be followed up annually for five years after a single
immunization1
Valneva is discussing with the FDA to bring VLA1553 to a potential licensure as soon
as possible
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Exclusive, worldwide partnership with Pfizer
FDA Fast Track Designation granted
Multivalent vaccine (six serotypes) to protect against Lyme disease in the
United States and Europe
Follows proven Mechanism of Action for a Lyme disease vaccine
Initial results reported from Phase 2 trials 1, 2, Recruitment completed for
Phase 2 trial VLA15-221 incl. pediatric participants3
VLA15 – Multivalent Lyme Disease Vaccine Candidate
Only Lyme Disease Program in Advanced Clinical Development Today
August 10, 2021Valneva H1 2021 Analyst Presentation 10
1
2
4
5
3
1 Valneva announces positive initial results for Phase 2 study of Lyme Disease vaccine candidate. 2 Valneva announces positive initial results for second Phase 2 study of Lyme Disease vaccine candidate
VLA15. 3 Valneva and Pfizer Complete Recruitment for Phase 2 Trial of Lyme Disease Vaccine Candidate
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VLA15: Development Progress
August 10, 2021Valneva H1 2021 Analyst Presentation 11
VLA15-221 recruitment completed with a total of 625 participants, 5 to 65 years of
age, randomized2
The trial triggered a milestone payment of $10 million, upon dosing of the first subject,
from Pfizer to Valneva
Topline results for VLA15-221 are expected in the first half of 2022.
VLA15-221 will also investigate a booster dose of VLA15, administered one year
following the 6 Month dose1
Phase 3 pivotal efficacy trial planned to commence pending positive readout from
VA15-221 in 20221
Clinical readout, based on one tick season, projected end 2023
Initial submission for regulatory approval anticipated in H2 2024, assuming positive
data
1Valneva and Pfizer Announce Initiation of Phase 2 Study for Lyme Disease Vaccine Candidate., 2 Valneva and Pfizer Complete Recruitment for Phase 2 Trial of Lyme Disease Vaccine
Candidate
Phase 2 trial1 in Adults and Pediatric Subjects Ongoing
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UK government deal worth up to €1.4 billion1 with development and manufacturing funding;
ongoing dialogue with the European Commission
Program acceleration enabled through use of Valneva’s FDA-registered facility in
UK; commercial manufacturing commenced January 202122
Phase 1/2 clinical trial results reported4, Phase 3 trial “Cov-Compare” fully
recruited4
Regulatory submission to MHRA planned in autumn 2021, deliveries thereafter, subject
to approval5
Combines Valneva’s proven approach of inactivated vaccines with Dynavax’s
advanced CpG 1018 adjuvant33
VLA2001 – The Only Inactivated Vaccine in Clinical
Development in Europe
August 10, 2021Valneva H1 2021 Analyst Presentation 12
Note: Photo credit: CDC/Alissa Eckert, MSMI; Dan Higgins, MAM. 1 Valneva announces major COVID-19 vaccine partnership with U.K. Government.2 Valneva commences
manufacturing of its Inactivated, Adjuvanted COVID-19 vaccine, completes Phase 1/2 study recruitment. 3 Valneva and Dynavax announce commercial supply agreement for
Inactivated, Adjuvanted COVID-19 vaccine; 4 Valneva Reports Positive Phase 1/2 Data for Its Inactivated, Adjuvanted COVID-19 Vaccine Candidate, VLA2001
1
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August 10, 2021Valneva H1 2021 Analyst Presentation 13
“Cov-Compare” (VLA2001-301) is a randomized, observer-blind, controlled, comparative immunogenicity trial in over 4,000 adults
Immunological comparison against a licensed vaccine to reasonably predict efficacy(superiority of VLA2001 in a two-dose immunization schedule four weeks apart - GMTs of neutralising antibodies, at two weeks after the second vaccination)
Study conducted in UK supported by DHSC/NIHR, including funding
Protocol agreed with MHRA; discussion with other regulatory bodies ongoing
Cov-Compare Phase 3 topline data expected early in the fourth quarter. Valneva expects to commence rolling submission with MHRA in the coming weeks and, subject to the Phase 3 data, believes that initial approval may be granted by the end of 2021.
Valneva participating in the world’s first COVID-19 vaccine booster trial in the UK2
Additional studies planned (including reduced booster dose)
Valneva studying other variants, to be in a position to manufacture variant-based
vaccines
VLA2001: Development Outlook
Pivotal Phase 3 trial “Cov-Compare” Recruitment Completed1
1 Valneva Completes Phase 3 Trial Recruitment for its Inactivated COVID-19 Vaccine Candidate, 2 Valneva to Participate in the World’s First COVID-19 Vaccine Booster Trial in the UK
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Agenda
August 10, 2021Valneva H1 2021 Analyst Presentation 14
Introduction
Business Update
Financial Report H1 2021
Newsflow
Q&A
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Results Dynamics and Outlook
Updated guidance including COVID-19 expected
Ongoing Phase 3 trials and regulatory discussions
Role of VLA2001 as a booster
Studying variants in order to be in a position to produce variant-based vaccines
Ongoing discussions with EC
Valneva reconfirms its 2021 financial guidance (excluding COVID-19)
Total revenues, excluding VLA2001, of €80 million to €105 million
R&D expenses, excluding VLA2001, of €65 million to €75 million
August 10, 2021Valneva H1 2021 Analyst Presentation 15
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IXIARO®
US Military €22.3m
TPP1
€5.9m
IXIARO®
JESPECT®
Travel €3.1m
H1 2021 Sales Adversely Affected by the COVID-19 Pandemic
August 10, 2021Valneva H1 2021 Analyst Presentation 16
Direct sales
98%
Gross
margin³
39.2%
Product sales (Unaudited)²
-22% AER / -19% CER
AER: Actual exchange rates, CER: Constant exchange rates; 1 Third party products sold by Valneva‘s commercial organization, 2 YoY comparison for same period, 3 Gross margin on
product sales
Net
product sales
€31.8m
DUKORAL®
€0.4m
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EBITDA Loss Reflecting Increasing R&D Expenses
H1 2021 Profit & Loss Report (unaudited)
August 10, 2021Valneva H1 2021 Analyst Presentation 17
1 EBITDA is a non-IFRS financial measure. A reconciliation to operating profit (loss), the most directly comparable financial measures calculated in accordance with IFRS, is included herein.
H1 2021 EBITDA was calculated by excluding €6.1 million (H1 2020: €4.7 million) of depreciation and amortization from the €86.2 million operating loss (H1 2020: €21.9 million) as recorded in the
consolidated income statement under IFRS.
€m H1 2021 H1 2020
Product sales 31.8 40.9
Revenues from collaboration, licensing and services 15.7 7.0
Revenues 47.5 47.9
Cost of goods (23.5) (18.1)
Cost of services (11.3) (4.4)
Research and development expenses (78.7) (33.1)
Marketing and distribution expenses (9.6) (10.0)
General and administrative expenses (20.9) (10.6)
Other income / (expense), net 10.4 6.5
Operating profit / (loss) (86.2) (21.9)
Finance, investment in associates & income taxes (0.2) (3.7)
Loss for the period (86.4) (25.6)
EBITDA1 (80.1) (17.2)
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Effect of COVID-19 Program on Group P&L
COVID-19 Program Reported as Separate Segment as of 2021
August 10, 2021Valneva H1 2021 Analyst Presentation 18
€m H1 2021Group
H1 2021COVID only
H1 2021excl. COVID
Product sales 31.8 31.8
Revenues from collaboration, licensing and services 15.7 15.7
Revenues 47.5 47.5
Cost of goods (23.5) (4.2) (19.3)
Cost of services (11.3) (11.3)
Research and development expenses (78.7) (46.1) (32.6)
Marketing and distribution expenses (9.6) (0.4) (9.2)
General and administrative expenses (20.9) (9.4) (11.5)
Other income / (expense), net 10.4 4.7 5.7
Operating profit / (loss) (86.2) (55.5) (30.7)
Finance, investment in associates & income taxes (0.2) (0.2)
Loss for the period (86.4) (55.5) (30.9)
EBITDA1 (80.1) (52.8) (27.3)
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Strong Cash Position of €329.8 million at End of June
August 10, 2021Valneva H1 2021 Analyst Presentation 19
Balance Sheet as of June 30, 2021
ASSETS Jun 30, 2021 Dec 31, 2020
NON-CURRENT ASSETS 183,145 140,737
+ Intangible Assets 34,424 35,409
+ Right Of Use Assets 48,239 43,374
+ Property, plant & equipment 74,789 34,779
+ Other non-current assets 25,693 27,176
CURRENT ASSETS 561,277 308,427
+ Inventories 125,664 26,933
+ Trade receivables 18,007 19,232
+ Other current assets 87,841 57,828
+ Cash & current financial assets 329,766 204,435
TOTAL ASSETS 744,422 449,164
EQUITY & LIABILITIES Jun 30, 2021 Dec 31, 2020
EQUITY 76,385 77,422
NON-CURRENT LIABILITIES 211,119 195,872
+ Borrowings, long term 47,402 46,375
+ Refund Liabilities 104,493 97,205
+ Other long term liabilities, including Lease Liabilities 59,224 52,292
CURRENT LIABILITIES 456,917 175,870
+ Trade payables and accruals 71,502 36,212
+ Borrowings, short term 7,079 6,988
+ Contract Liabilities 338,474 89,578
+ Refund Liabilities 6,875 14,222
+ Other current liabilities, including Lease Liabilities 32,987 28,871
TOTAL EQUITY AND LIABILITIES 744,422 449,164
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Agenda
August 10, 2021Valneva H1 2021 Analyst Presentation 20
Introduction
Business Update
Financial Report H1 2021
Newsflow
Q&A
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Key Upcoming Catalysts and Potential Inflection Points
August 10, 2021Valneva H1 2021 Analyst Presentation 21
Lyme disease vaccine candidate VLA15
Further Phase 2 milestones and read-outs
Chikungunya vaccine candidate VLA1553
Final Phase 3 trial results
Topline data of clinical lot-to-lot consistency Phase 3 trial
COVID-19 vaccine candidate VLA2001
Clinical results including Cov-Compare and COV-Boost
Marketing authorization submission, subject to data
Further clinical development plans to complement UK trials
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Supplemental Disclosures Regarding Non-IFRS Financial
Measures
EBITDA is a common supplemental measure of performance used by investors and financial analysts.
Management believes this measure provide additional analytical tools. EBITDA is defined as earnings
(loss) from continuing operations before interest expense, income taxes, depreciation and amortization.
A reconciliation of EBITDA to operating profit (loss), the most directly comparable IFRS measure, is set
forth below:
August 10, 2021Valneva H1 2021 Analyst Presentation 22
€ in million 6 months ending June 30
2021 2020
Operating (loss)/Profit (86.2) (21.9)
Add:
Amortization 3.1 3.0
Depreciation 3.0 1.7
EBITDA (80.1) (17.2)
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Agenda
August 10, 2021Valneva H1 2021 Analyst Presentation 23
Introduction
Business Update
Financial Report H1 2021
Newsflow
Q&A
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Thank you
Merci
Danke
Tack